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A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19
Ray Y, Paul SR, Bandopadhyay P, D'Rozario R, Sarif J, Raychaudhuri D, Bhowmik D, Lahiri A, Vasudevan JS, Maurya R, et al
Nature communications. 2022;13(1):383
Abstract
A single center open label phase 2 randomised control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess clinical and immunological benefits of passive immunization using convalescent plasma therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 patients hospitalized with severe COVID-19 disease and fulfilling the inclusion criteria (aged more than 18 years, with either mild ARDS having PaO2/FiO2 200-300 or moderate ARDS having PaO2/FiO2 100-200, not on mechanical ventilation) were recruited and randomized into either standard of care (SOC) arm (N = 40) or the convalescent plasma therapy (CPT) arm (N = 40). Primary outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of response to therapy if any, for which plasma abundance of a large panel of cytokines was quantitated before and after intervention to assess the effect of CPT on the systemic hyper-inflammation encountered in these patients. The secondary outcomes were recovery from ARDS and time taken to negative viral RNA PCR as well as to report any adverse reaction to plasma therapy. Transfused convalescent plasma was characterized in terms of its neutralizing antibody content as well as proteome. The trial was completed and it was found that primary outcome of all-cause mortality was not significantly different among severe COVID-19 patients with ARDS randomized to two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% confidence interval 0.3010-1.505, with a P value of 0.3424 on Mantel-Cox Log-rank test). No adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS no significant clinical benefit was registered in this clinical trial with convalescent plasma therapy in terms of prespecified outcomes.
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Effect of Albumin Addition to Cardiopulmonary Bypass Prime on Outcomes in Children Undergoing Open-Heart Surgery (EACPO Study)-A Randomized Controlled Trial
Rauf A, Joshi RK, Aggarwal N, Agarwal M, Kumar M, Dinand V, Joshi R
World journal for pediatric & congenital heart surgery. 2020;:2150135120959088
Abstract
BACKGROUND There is a paucity of literature regarding the association of high oncotic priming solutions for pediatric cardiopulmonary bypass (CPB) and outcomes, and no consensus exists regarding the composition of optimal CPB priming solution. This study aimed to examine the impact of high oncotic pressure priming by the addition of 20% human albumin on outcomes. METHODS Double-blinded, randomized controlled study was done in the pediatric cardiac intensive care unit of a tertiary care hospital. Consecutive children with congenital heart diseases admitted for open-heart surgery were randomized into two groups, where the study group received an additional 20% albumin to conventional blood prime before CPB initiation. RESULTS We enrolled 39 children in the high oncotic prime (added albumin) group and 37 children in the conventional prime group. In the first 24-hour postoperative period, children in the albumin group had significantly lower occurrence of hypotension (28.2% vs 54%, P = .02), requirement of fluid boluses (25.6% vs 54%, P = .006), and lactate clearance time (6 vs 9 hours, P < .001). Albumin group also had significantly higher platelet count (×10(3)/µL) at 24 hours (112 vs 91, P = .02). There was no significant difference in intra-CPB hemodynamic parameters and incidence of acute kidney injury. In subgroup analysis based on risk category, significantly decreased intensive care unit stay (4 vs 5 days, P = .04) and hospital stay (5 vs 7 days, P = .002) were found in the albumin group in low-risk category. CONCLUSION High oncotic pressure CPB prime using albumin addition might be beneficial over conventional blood prime, and our study does provide a rationale for further studies.
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Comparative evaluation of bone regeneration with platelet-rich fibrin in mandibular third molar extraction socket: A randomized split-mouth study
Malhotra A, Kapur I, Das D, Sharma A, Gupta M, Kumar M
National journal of maxillofacial surgery. 2020;11(2):241-247
Abstract
PURPOSE Platelet-rich fibrin (PRF) is a new platelet concentrate concept consisting of an autologous fibrin gel having accumulation of platelets and the released cytokines in a fibrin clot. The study aims to evaluate the efficacy of autologous PRF in accelerating bone regeneration and repair in fresh third molar extraction sockets. The investigators hypothesized the cicatricial properties and accumulation of growth factors in a single clot which will improve bone density and quality. MATERIALS AND METHODS PRF results from a natural and progressive polymerization occurring during centrifugation. Two groups were made with bilaterally impacted third molar patients. PRF was obtained and surgical extraction was carried out under aseptic conditions. Quantitative data are presented as mean. Statistical significance was inferred at P < 0.05. RESULTS Results obtained were evaluated statistically and found a significant difference between the groups in improvement in alveolar bone density of regenerate measured radiographically. The study demonstrates a faster bone formation in the extracted sockets with PRF as compared to control. CONCLUSION PRF proved to be an autologous biomaterial with useful features that allowed efficient postextraction bone defect filling and faster bone regeneration.
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Comparison of Blood-Conserving and Allogenic Transfusion-Sparing Effects of Antifibrinolytics in Scoliosis Correction Surgery
Ramkiran S, Kumar M, Krishnakumar L, Nair SG
Anesthesia, essays and researches. 2020;14(2):259-265
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Abstract
BACKGROUND Intraoperative antifibrinolytic drug administration is a safe and effective method of reducing blood loss and allogenic transfusions in patients undergoing spine deformity correction. AIM: This study aimed to compare the effectiveness of two antifibrinolytic drugs tranexamic acid (TXA) and epsilon amino caproic acid (EACA) in reducing peri-operative blood loss and transfusion requirements against a placebo control in patients with idiopathic scoliosis undergoing correction surgery. SETTING AND DESIGN This is a prospective, randomized, double-blinded, controlled comparative study. METHODOLOGY Patients in TXA group received 50 mg.kg(-1) bolus and 10 mg.kg(-1).h(-1) infusion as against 100 mg.kg(-1) and 10 mg.kg(-1).h(-1) infusion in EACA group. The placebo group had saline bolus and infusion. Parameters observed included baseline demographic and deformity data, duration of surgery, total peri-operative blood loss, and allogenic packed red cell transfusion requirements. STATISTICAL ANALYSIS Mean and standard deviation were used to represent the quantitative continuous data, and percentage was used to represent categorical data. The Student's t-test and ANOVA were used to compare means between groups. Bonferroni's multiple comparison test was used to find out the association between categorical variables. RESULTS A total of 36 patients were enrolled with 12 patients in each group. Peri-operative blood loss was 50.1% lower in patients receiving TXA and 17.7% lower in patients receiving EACA compared with the placebo group. The volume of total packed red cell transfusion was 66.7% lower in patients receiving TXA and 45.6% lower in patients receiving EACA compared with placebo. CONCLUSION TXA was more effective in reducing total peri-operative blood loss and allogenic transfusion requirement in idiopathic scoliosis correction surgery compared to EACA.
PICO Summary
Population
Patients with idiopathic scoliosis undergoing correction surgery (n= 36).
Intervention
Tranexamic acid (TXA, n= 12).
Comparison
Epsilon amino caproic acid (EACA, n= 12). Placebo (saline, n= 12).
Outcome
Peri-operative blood loss was 50.1% lower in patients receiving TXA and 17.7% lower in patients receiving EACA compared with the placebo group. The volume of total packed red cell transfusion was 66.7% lower in patients receiving TXA and 45.6% lower in patients receiving EACA compared with placebo.
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Additive Effect of Platelet Rich Fibrin with Coronally Advanced Flap Procedure in Root Coverage of Miller's Class I and II Recession Defects-A PRISMA Compliant Systematic Review and Meta-Analysis
Panda S, Satpathy A, Chandra Das A, Kumar M, Mishra L, Gupta S, Srivastava G, Lukomska-Szymanska M, Taschieri S, Del Fabbro M
Materials (Basel, Switzerland). 2020;13(19)
Abstract
AIM: This systematic review and meta-analysis aims to assess the additive effect of leukocyte and platelet-rich fibrin (L-PRF) on coronally advanced flap (CAF) procedures in root coverage of Miller's class I and II gingival recession defects. Review methodology: A comprehensive search in MEDLINE (PubMed), Scopus and CENTRAL (the Cochrane Central Register of Controlled Trials), along with an additional hand search, provided eight randomized clinical trials to be included in this review. A total of 167 patients with 470 gingival recession defects were analyzed. A meta-analysis was carried out to assess the change in gingival thickness (GT), width of keratinized gingiva (WKG), root coverage percentage (%RC), clinical attachment level (CAL) and recession depth (RD) at all follow-ups between CAF alone and CAF + L-PRF groups for all included studies. A subgroup analysis was carried out based on recession type (single/multiple). RESULTS Overall, a significant improvement in GT, CAL and RD was found when treated with CAF + L-PRF. There was a trend for a positive effect in terms of an increase in WKG when using L-PRF, especially in the treatment of single recession, though significance was not achieved (p = 0.08 overall). The results of heterogeneity among the subgroups were varied and were found to be greater than 91.3% for GT and 32.8% for WKG. CONCLUSION L-PRF when used in addition to CAF showed favorable results for the treatment of class I and II gingival recession defects.
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Plasma rich in growth factors (PRGF) in non-surgical periodontal therapy: a randomized clinical trial
Panda S, Purkayastha A, Mohanty R, Nayak R, Satpathy A, Das AC, Kumar M, Mohanty G, Panda S, Fabbro MD
Braz Oral Res. 2020;34:e034
Abstract
The aim of this split mouth, double blinded, randomized clinical trial was to evaluate the clinical efficacy of use of Plasma rich in growth factors (PRGF) as an adjunct to scaling and root planing (SRP) in the treatment of periodontal pockets. Twenty six patients (15 males, 11 females) diagnosed with generalized periodontitis with Pocket Depth > 5mm and plaque index score < 1.5, were randomly allocated by using computer generated random sequence, into two groups, one treated with intra-pocket application of PRGF adjunct to SRP and other with SRP alone. The clinical outcomes like pocket depth (PD), relative attachment level (RAL) and sulcus bleeding index (SBI) were assessed at baseline, 3 months and 6 months. Twenty two patients (44 sites) were analyzed at the end of 6 month follow-up, using SPSS 20.0v software. There was a significant statistical difference observed between both the groups favouring SRP +PRGF group in terms of PD (p = 0.007) and RAL (p = 0.021) at the end of 6 month follow-up. Also there was a statistical significant difference (< 0.001) at all time points compared to baseline, for all parameters in intra-group comparison. Moreover, the sites with PD>4mm necessitating further treatment after 6-month follow-up were significantly lesser for SRP+PRGF group. The use of PRGF technology in non-surgical periodontal therapy, by single intra-pocket application in to periodontal pockets as an adjunct to SRP, in chronic periodontitis patients, was found to be effective in reduction of pocket depth and gain in clinical attachment level.
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Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial
Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, et al
Hepatology (Baltimore, Md.). 2019
Abstract
Thromboelastography (TEG) provides a more comprehensive global coagulation assessment than routine tests (international normalized ratio [INR] and platelet [PLT] count), and its use may avoid unnecessary blood component transfusion in patients with advanced cirrhosis and significant coagulopathy who have nonvariceal upper gastrointestinal (GI) bleeding. A total of 96 patients with significant coagulopathy (defined in this study as INR >1.8 and/or PLT count <50 x 10(9) /L) and nonvariceal upper GI bleed (diagnosed after doing upper gastrointestinal endoscopy [UGIE], which showed ongoing bleed from a nonvariceal source) were randomly allocated to TEG-guided transfusion strategy (TEG group; n = 49) or standard-of-care (SOC) group (n = 47). In the TEG group, only 26.5% patients were transfused with all three blood components (fresh frozen plasma [FFP], PLTs, and cryoprecipitate) versus 87.2% in the SOC group (P < 0.001). Whereas 7 (14.3%) patients in the TEG group received no blood component transfusion, there were no such patients in the SOC group (P = 0.012). Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared to the SOC group. Failure to control bleed, failure to prevent rebleeds, and mortality between the two groups were similar. CONCLUSION In patients with advanced cirrhosis with coagulopathy and nonvariceal upper GI bleeding, TEG-guided transfusion strategy leads to a significantly lower use of blood components compared to SOC (transfusion guided by INR and PLT count), without an increase in failure to control bleed, failure to prevent rebleed, and mortality.
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Combination of granulocyte colony-stimulating factor and erythropoietin improves outcomes of patients with decompensated cirrhosis
Kedarisetty CK, Anand L, Bhardwaj A, Bhadoria AS, Kumar G, Vyas AK, David P, Trehanpati N, Rastogi A, Bihari C, et al
Gastroenterology. 2015;148((7)):1362-1370.e7.
Abstract
BACKGROUND & AIMS Patients with decompensated cirrhosis have significantly reduced survival without liver transplantation. Granulocyte colony-stimulating factor (G-CSF) has been shown to increase survival in patients with acute-on-chronic liver failure, and erythropoietin promoted hepatic regeneration in animal studies. We performed a double-blind, randomized, placebo-controlled trial to determine whether co-administration of these growth factors improved outcomes for patients with advanced cirrhosis. METHODS In a prospective study, consecutive patients with decompensated cirrhosis seen at the Institute of Liver and Biliary Sciences, New Delhi (from May 2011 through June 2012) were randomly assigned to groups given subcutaneous G-CSF (5 mug/kg/d) for 5 days and then every third day (12 total doses), along with subcutaneous darbopoietin alpha(40 mcg/wk) for 4 weeks (GDP group, n = 29), or only placebos (control group, n = 26). All patients also received standard medical therapy and were followed for 12 months. Histology was performed on liver biopsies. The primary end point was survival at 12 months. RESULTS Baseline characteristics of patients were comparable; alcohol intake was the most common etiology of cirrhosis. A higher proportion of patients in the GDP group than controls survived until 12 months (68.6% vs 26.9%; P = .003). At 12 months, Child-Turcotte Pugh scores were reduced by 48.6% in the GDP group and 39.1% in the control group, from baseline (P = .001); Model for End Stage Liver Disease scores were reduced by 40.4% and 33%, respectively (P = .03). The need for large-volume paracentesis was significantly reduced in GDP group, compared with controls (P < .05). A lower proportion of patients in the GDP group developed septic shock (6.9%) during follow-up compared with controls (38.5%; P = .005). No major adverse events were observed in either group. CONCLUSIONS In a single-center randomized trial, a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF and darbopoietin alpha survived for 12 months more than patients given only placebo. The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo. Clinicaltrials.gov ID: NCT01384565.Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.